Pharmaceutical industry characteristics toxicity

Table 9-2. Summary of the characteristics of the developmental toxicity assays used in pharmaceutical industry... 

In some industries, special material characteristics, such as heat and/or pressure sensitivity, toxicity, reactivity, etc., are of importance. Particularly in the pharmaceutical industry and some sectors of chemistry these parameters must be considered. While pressure agglomeration methods have only limited applicability for heat- and/or pressure-sensitive materials, toxicity may limit the appeal of tumble agglomeration because of the difficulty to contain dust and avoid contamination of the environment. 

Green chemistry imposes additional constraints on the product and process characteristics. The issues are different for different product sectors and industries. Thus, the specialty chemicals and the pharmaceuticals industries use many different types of synthetic organic reactions. The product volume may be small, but the purities expected are very high. They are very dependent on solvents, as both reactants and products are often solids, and produced molecules may possess toxicity and have other effects on the environment. The most important issues are atom efficiency of individual reactions, solvent recovery and reuse, use of benign solvents, product toxicity, and product end-of-life. Such data for all their raw materials and products may not be available. 

Polymorphism is a characteristic of the solid state and the concept is immensely important in the pharmaceutical industry. Properties such as stability, solubility, bioavailability, manufacturability, tableting, formulation, and even toxicity are a function of the polymorph crystal structure. 

Usually sterilization is performed at sufficiently high temperatures that may cause damage on same materials used in food processing industry, pharmaceutical industry and cosmetics. The effect of ozone on bacteria is well known, especially its toxicity and reactivity characteristics that is why attention should be given to dosage and C5q)osure time. 

The Swedish Classification Scheme initiated in 2005 by the Swedish Association of Pharmacy Industries (LIF), the Swedish Medical Products Agency, Apoteket (National Corporation of Swedish Pharmacies), the Swedish Association of Local Authorities and Regions and the Stockholm County Council, take in account Persistence, Bioaccumulation and Toxicity (PBT) characteristics of pharmaceutical products. This voluntary scheme looks at the environmental hazard and the associated risk of pharmaceutical products. The environmental risk is calculated based on the ratio PEC/PNEC according to the EMEA guideline [17,124, 127]. The obtained information is only available on the website www.fss.se, since due to European restrictions it is not possible to include warning labels on the packaging of medications [17]. 

Chitosan, the most abundant marine mucopolysaccharide, is derived from chitin by alkaline deacetylation, and possesses versatile biological properties such as biocompatibility, biodegradability, and a non-toxic nature. Due to these characteristics, considerable attention has been given to its industrial applications in the food, pharmaceutical, agricultural, and environmental industries. Currently, chitosan can be considered as a potential marine nutraceutical because its remarkable biological activities have been investigated and reported, in order to exploit its nutraceutical... 

Formation of corrosion products with particular characteristics, dependent on the specific field of use, such as nonaesthetic corrosion products iu the decorative field, opaque in the optical field, insulators in the field of heat exchangers or in that of electrical contacts, dyes in the textile field or in the cleaning field, toxic in the pharmaceutical field or in the food industry, abrasives where there are mechanical components in motion, or with undesired catalytic properties wherever chemical reactions are possible... 

Two reviews (in Japanese) have appeared on aspects of cyclodextin chemistry a) on structure, physical properties, toxicity, metabolism, entrapping characteristics and uses in the pharmaceutical and food industries, and on the construction of chemically modified cyclodextrins that recognize anions. ... 

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